INFORMED CONSENT IN EMERGENCY RESEARCH - CONSENSUS STATEMENT FROM THECOALITION CONFERENCE OF ACUTE RESUSCITATION AND CRITICAL CARE RESEARCHERS

Objective.-A coalition conference of acute resuscitation researchers w as held to discuss the feasibility of applying current federal researc h regulations regarding informed consent to the emergency setting. Thi s article presents consensus recommendations for regulatory changes fo r consent in emergency research.Participants.-Representatives from the Society for Academic Emergency Medicine and the American Heart Associ ation identified several professional organizations as stakeholders in this issue, including research, clinical, bioethics, legal, and patie nt advocacy groups. The Office for Protection From Research Risks (OPR R), the Food And Drug Administration (FDA), and staff from specific le gislative offices were also invited to observe. Forty-three participan ts attended, including representatives from 12 professional organizati ons, five medical institutions, and the FDA and OPRR. This was a close d meeting. Participants were self-funded or sponsored by their profess ional organizations. Evidence.-Before the meeting, a draft of a positi on statement was developed by the conference organizers based on the c urrent literature and discussions with experts in the field. This draf t, copies of the current federal research regulations, and supporting articles were distributed before the conference. Consensus Process.-Pa rticipants rotated through moderated discussion sessions to comment on subsections of the draft. Following discussion, a working draft was d eveloped and distributed to each participant and represented organizat ional board for final review. All comments were considered in the fina l version of the document. Conclusions.-We believe there are circumsta nces when it is not feasible to obtain prospective or proxy consent fo r enrollment into an emergency research protocol. In these circumstanc es, patients are vulnerable, not only to research risks, but also to b eing denied potentially beneficial therapy when there is no known effe ctive treatment for their life-threatening condition. We offer recomme ndations that should be met when the critical nature of the illness or injury or the need to apply an investigational therapy rapidly preclu des prospective consent for participation in emergency research.